Skip to content

Transcutaneous vagus nerve stimulation for improvement of postoperative ileus after minimally invasive colorectal resection: a randomized controlled study

Transcutaneous vagus nerve stimulation for improvement of postoperative ileus after minimally invasive colorectal resection: a randomized controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083015
Enrollment
Unknown
Registered
2024-04-13
Start date
2024-04-15
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal cancer

Interventions

True stimulus :Patients in the stimulation group received low-intensity stimulation on right concha sulcus, with a frequency of 25 Hz and a pulse width of 250µs, 30s on /30s off. The stimulation began
Sham stimulus (control group):Patients in the sham stimulation group received the same treatment cycle as the stimulation group, and the sham stimulation was placed through the electrode on the right
Frequency: 25Hz) will be initiated at 10mA, gradually increasing the stimulus intensity until a "tingling sensation" is reported within 20 s of onset, at which time the current is switched off.

Sponsors

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: ? Age =18 years old. ? Understand the research process and the use of various assessment scales, and can effectively communicate with researchers. ? Voluntarily participated in this study and signed the informed consent. ? Elective minimally invasive (laparoscopic or robotic) colorectal surgery under general anesthesia. ? ASA I-III.

Exclusion criteria

Exclusion criteria: ?Severe heart disease (myocardial infarction within the previous 12 months, New York Heart Association class =3, heart failure, second - or third-degree atrioventricular block, permanent atrial fibrillation/flutter, or previous ventricular tachycardia/fibrillation); ? Recurrent seizures or syncope in the last 5 years; ? Previous transient ischemic attack or cerebrovascular accident; ? Previous vagotomy at any anatomical site; ? Chronic gastrointestinal inflammation was diagnosed; ? Neuroendocrine tumor was diagnosed; ? Indwelling gastrointestinal stoma; ? Implantation of an electrical stimulation device (e.g., a pacemaker or defibrillator); ? Abnormal anatomical structure of the neck may affect the use of the equipment; ? Belong to vulnerable groups (e.g. lack of capacity, prisoners, etc.); ? Pregnancy, lactation or preparation during the study period; ? Patients with a history of abdominal surgery or intestinal obstruction; ? Other organs were resected; ? Conversion to open surgery or total colectomy; ? The patient requiring long-term intensive care due to intraoperative or postoperative complications (> 1 day); ? Patients who received vagus nerve stimulation or acupuncture within 1 month before the study; ? Patients who are participating in other clinical trials; ? Patients with ear dermatitis;

Design outcomes

Primary

MeasureTime frame
Time to first defecation after the operation;

Secondary

MeasureTime frame
Intervention-related adverse events;Basic information and past medical history;Surgical conditions;Postoperative Indicators;Laboratory indicators (postoperative);

Countries

China

Contacts

Public ContactGang Chen

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

chengang120@zju.edu.cn+86 137 5711 8681

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026